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Completed

NCT Number: NCT03426709

Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care.

The aim of this study is to assess the efficacy in Primary Care (PC) of a low intensity psychological intervention applied using Information and communication technologies (ICTs) for the treatment of multimorbidity in PC (depression and diabetes/low back pain) by a randomized controlled trial (RCT). A protocol will be design that combines face to face intervention with a supporting online program that will be tried in a RCT conducted in 3 different regions (Andalucía, Aragón, y Baleares). Our main hypothesis is that improved usual care combined with psychological therapy applied by ICTs, will be more efficacious to improve the symptomatology of multimorbidity, compared to a group with only improved treatment as usual three months after the end of treatment.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Chronic Disease Chronic Disease (Diabetes/Low Back Pain) Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Science Research Institute, University Balearic Islands, Palma de Mallorca, Mallorca, Spain

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About this study

Although multimorbidity is highly prevalent, health care systems are designed for the management individual diseases. New strategies are needed to help general practitioners to provide appropriate personalized care to patients. The World Health Organization (WHO) has included comorbidity between depression and a chronic disease as one of the 10 main priorities in global public health. Studies in meta-analysis confirm that the 2 main interventions of first choice for depression are pharmacotherapy and/or psychotherapy, with similar results in the short term but superior in the long term for psychological treatments. Given the difficulty of delivering face to face psychological treatments (high costs) alternative models of delivering treatments have been proposed, emphasizing the role of technologies like Internet. The aim of this study is to assess the efficacy in Primary Care (PC) of a low intensity psychological intervention (8 weeks) applied using Information and communication technologies (ICTs) for the treatment of multimorbidity in PC (depression and diabetes/low back pain) by a randomized controlled trial (RCT). Our main hypothesis is that improved usual care combined with psychological therapy applied by ICTs, will be more efficacious to improve the symptomatology of multimorbidity, compared to a group with only improved treatment as usual three months after the end of treatment. A protocol will be design that combines face to face intervention with a supporting online program that will be tried in a RCT conducted in 3 different regions (Andalucía, Aragón, y Baleares). 180 participants diagnosed with depression and diabetes/low back pain will participate in the RCT. It´s proposed a coordinated study by 4 highly experienced groups with great possibilities of translation and transference to usual clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be adult
  • Willingness to participate in the study and signing informed consent
  • Ability to understand oral and written Spanish.
  • DSM-5 diagnose of Major Depression or Dysthymia, mild or moderate depression expressed as score lower than 19 in the Patient Health Questionnaire (PHQ-9)
  • Duration of depressive symptoms 2 months or more
  • Diagnosis of one of the following two conditions: Diabetes (Diagnosis according to criteria of the American Diabetes Association (ADA)) or low back pain (Diagnosis of non-specific chronic low back pain according to the definition established by the Clinical Practice Guide of the European Program COST B-13 (CPG COST B-13) with a duration of at least 6 months)
  • To have and to handle the computer, internet and mobile phone

Exclusion criteria

  • Any diagnose of disease that may affect central nervous system (brain pathology, traumatic brain injury, dementia, etc.),
  • Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.), except for anxious pathology or personality disorders
  • Any medical, infectious or degenerative disease that may affect mood
  • Presence of delusional ideas or hallucinations consistent or not with mood
  • Suicide risk

Treatment and study plan

Low intensity Internet-delivered psychotherapy

Behavioral

The online intervention will be individual and interactive, which will be supported by multimedia material (videos, sound recordings, etc.) and will have internet support. The estimated duration of the program is 8 weeks. Low Intensity Internet-delivered psychotherapy: Psychoeducation, Healthy living habits, Behavioral activation, Positive Psychology, Mindfulness and Compassion

Primary outcomes

  1. Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline

    In the Intervention group. The Patient Health Questionnaire (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The possible range is 0-27.

  2. Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline

    In the TAU control group. The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The possible range is 0-27.

  3. Patient Health Questionnaire (PHQ-9)

    Time frame: Post-treatment 8-12 weeks from baseline in the intervention group

    The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The possible range is 0-27.

  4. Patient Health Questionnaire (PHQ-9)

    Time frame: Post-treatment 8-12 weeks from baseline in the TAU control group

    The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The possible range is 0-27.

  5. Patient Health Questionnaire (PHQ-9)

    Time frame: 3 months follow up in the intervention group

    The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The possible range is 0-27.

  6. Patient Health Questionnaire (PHQ-9)

    Time frame: 3 months follow up in the TAU control group

    The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The possible range is 0-27.

  7. Patient Health Questionnaire (PHQ-9)

    Time frame: Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months).

    The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The possible range is 0-27.

  8. Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)

    Time frame: Baseline

    In the Intervention group

  9. Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)

    Time frame: Baseline

    In the TAU control group

  10. Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)

    Time frame: Post-treatment 8-12 weeks from baseline in the intervention group

  11. Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)

    Time frame: Post-treatment 8-12 weeks from baseline in the TAU control group

  12. Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)

    Time frame: 3 months follow up in the intervention group

  13. Visual Analog Scale (0-100) or Numeric Pain Scale (0-10)

    Time frame: 3 months follow up in the TAU control group

  14. Roland Morris Disability Questionnaire (RMDQ)

    Time frame: Baseline

    In the Intervention group. The Roland Morris Disability Questionnaire (RMDQ) consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/ activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). It is designed to take approximately 5 minutes to complete, without any assistance from the administrator. The RMDQ is scored by adding up the number of items checked by the patient (1 if is checked, 0 if is not). The score can range from 0 (no disability) to 24 (maximal disability).

  15. Roland Morris Disability Questionnaire (RMDQ)

    Time frame: Baseline

    In the TAU control group. The Roland Morris Disability Questionnaire (RMDQ) consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/ activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). It is designed to take approximately 5 minutes to complete, without any assistance from the administrator. The RMDQ is scored by adding up the number of items checked by the patient (1 if is checked, 0 if is not). The score can range from 0 (no disability) to 24 (maximal disability).

  16. Roland Morris Disability Questionnaire (RMDQ)

    Time frame: Post-treatment 8-12 weeks from baseline in the intervention group

    The Roland Morris Disability Questionnaire (RMDQ) consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/ activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). It is designed to take approximately 5 minutes to complete, without any assistance from the administrator. The RMDQ is scored by adding up the number of items checked by the patient (1 if is checked, 0 if is not). The score can range from 0 (no disability) to 24 (maximal disability).

  17. Roland Morris Disability Questionnaire (RMDQ)

    Time frame: Post-treatment 8-12 weeks from baseline in the TAU control group

    The Roland Morris Disability Questionnaire (RMDQ) consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/ activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). It is designed to take approximately 5 minutes to complete, without any assistance from the administrator. The RMDQ is scored by adding up the number of items checked by the patient (1 if is checked, 0 if is not). The score can range from 0 (no disability) to 24 (maximal disability).

  18. Roland Morris Disability Questionnaire (RMDQ)

    Time frame: 3 months follow up in the intervention group

    The Roland Morris Disability Questionnaire (RMDQ) consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/ activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). It is designed to take approximately 5 minutes to complete, without any assistance from the administrator. The RMDQ is scored by adding up the number of items checked by the patient (1 if is checked, 0 if is not). The score can range from 0 (no disability) to 24 (maximal disability).

  19. Roland Morris Disability Questionnaire (RMDQ)

    Time frame: 3 months follow up in the TAU control group

    The Roland Morris Disability Questionnaire (RMDQ) consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/ activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). It is designed to take approximately 5 minutes to complete, without any assistance from the administrator. The RMDQ is scored by adding up the number of items checked by the patient (1 if is checked, 0 if is not). The score can range from 0 (no disability) to 24 (maximal disability).

  20. Diabetes control measured by VR d= Hb glucosidal

    Time frame: Baseline

    In the Intervention group

  21. Diabetes control measured by VR d= Hb glucosidal

    Time frame: Baseline

    In the TAU control group

  22. Diabetes control measured by VR d= Hb glucosidal

    Time frame: Post-treatment 8-12 weeks from baseline in the intervention group

  23. Diabetes control measured by VR d= Hb glucosidal

    Time frame: Post-treatment 8-12 weeks from baseline in the TAU control group

  24. Diabetes control measured by VR d= Hb glucosidal

    Time frame: 3 months follow up in the intervention group

  25. Diabetes control measured by VR d= Hb glucosidal

    Time frame: 3 months follow up in the TAU control group

Secondary outcomes

  1. Sociodemographic data Gender, age, marital status, education, occupation, economical level

    Time frame: Baseline

    In the Intervention group and the TAU control group

  2. The Mini-International Neuropsychiatric Interview (MINI)

    Time frame: Baseline

    In the Intervention group and the TAU control group. This is a short structured diagnostic psychiatric interview that yields key DSM-IV and ICD-10 diagnoses. MINI can be administered in a short period of time and clinical interviewers need only a brief training. The MINI has been translated and validated in Spanish.

  3. Health Survey 12 (SF-12)

    Time frame: Baseline

    In the Intervention group

  4. Health Survey 12 (SF-12)

    Time frame: Baseline

    In the TAU control group

  5. Health Survey 12 (SF-12)

    Time frame: Post-treatment 12 weeks from baseline in the intervention group

  6. Health Survey 12 (SF-12)

    Time frame: Post-treatment 12 weeks from baseline in the TAU control group

  7. Health Survey 12 (SF-12)

    Time frame: 3 months follow up in the intervention group

  8. Health Survey 12 (SF-12)

    Time frame: 3 months follow up in the TAU control group

  9. Client Service Receipt Inventory (CSRI)

    Time frame: Baseline

    In the Intervention group

  10. Client Service Receipt Inventory (CSRI)

    Time frame: Baseline

    In the TAU control group

  11. Client Service Receipt Inventory (CSRI)

    Time frame: Post-treatment 12 weeks from baseline in the intervention group

  12. Client Service Receipt Inventory (CSRI)

    Time frame: Post-treatment 12 weeks from baseline in the TAU control group

  13. Client Service Receipt Inventory (CSRI)

    Time frame: 3 months follow up in the intervention group

  14. Client Service Receipt Inventory (CSRI)

    Time frame: 3 months follow up in the TAU control group

  15. Positive and Negative Affect Schedule (PANAS)

    Time frame: Baseline in the intervention group and TAU control group

    The PANAS is a self-report questionnaire that measure positive and negative affect and consists of a list of 20 adjectives (10 positive: e.g., "interested", and 10 negative: e.g., "guilty") that are rated on a 5-point Likert-type scale. This questionnaire has already been validated in the Spanish population with appropriate psychometric characteristics (Sandin et al., 1999).

  16. Positive and Negative Affect Schedule (PANAS)

    Time frame: 3 months follow up in the intervention group and TAU control group

    The PANAS is a self-report questionnaire that measure positive and negative affect and consists of a list of 20 adjectives (10 positive: e.g., "interested", and 10 negative: e.g., "guilty") that are rated on a 5-point Likert-type scale. This questionnaire has already been validated in the Spanish population with appropriate psychometric characteristics (Sandin et al., 1999).

  17. Positive and Negative Affect Schedule (PANAS)

    Time frame: Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months).

    The PANAS is a self-report questionnaire that measure positive and negative affect and consists of a list of 20 adjectives (10 positive: e.g., "interested", and 10 negative: e.g., "guilty") that are rated on a 5-point Likert-type scale. This questionnaire has already been validated in the Spanish population with appropriate psychometric characteristics (Sandin et al., 1999).

  18. Positive and Negative Affect Schedule (PANAS)

    Time frame: Post-treatment 12 weeks from baseline in the intervention and TAU control group

    The PANAS is a self-report questionnaire that measure positive and negative affect and consists of a list of 20 adjectives (10 positive: e.g., "interested", and 10 negative: e.g., "guilty") that are rated on a 5-point Likert-type scale. This questionnaire has already been validated in the Spanish population with appropriate psychometric characteristics (Sandin et al., 1999).

  19. Usefulness

    Time frame: Every week, after the completion of the corresponding module, until the end of the intervention (for an average of 2 months).

    A single question about usefulness (i.e., "To what extent has this module been useful to you?" (Lopez-Montoyo et al., 2019); with a Likert-type response option that ranges between 0 = "nothing" and 10 = "very much").

  20. System Usability Scale (SUS)

    Time frame: Post module 1 (Psychoeducation) after an average of 1 week

    The SUS is a 10-item questionnaire that measures usability in relation to the quality and acceptability of the intervention (i.e., "I think that I would like to use this system frequently"; with a Likert-type response option that ranges between 1 = "strongly disagree" and 5 = "strongly agree") (Bangor et al., 2008).

Sponsors and collaborators

Lead sponsor

Javier Garcia Campayo

Other

Collaborators

  • Carlos III Health Institute

Registry information

Official study title

Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care. A Randomized Clinical Trial.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 8, 2018
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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